A Study of Experimental Magnesium Infusion for Pain Management in Critically Ill Trauma Patients

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: pain management
Type: Drug study, Phase 4
Target:
156 Participants
Investigator:
Description
Magnesium is a naturally occurring mineral that is important for your body and brain. Magnesium sulfate (study drug) is a medication containing magnesium. It is commonly used to improve low blood levels of magnesium.

Magnesium sulfate has also proven to be successful in managing pain before and after surgery. This drug has primarily been used for pain control in patients undergoing surgery. Patients in the ICU with injuries also need good pain control.

Using magnesium may decrease the need for narcotics (pain relievers). It may also provide another non-narcotic drug for pain control.

The purpose of this study is to test the effectiveness of continuous, intravenous (into or within a vein using a needle) administration of magnesium sulfate. This will be compared to intravenous normal saline (salt solution).
This study requires

If you decide that you want to be in this study, the study doctor or member of the study staff will review with you all of the conditions that qualify or disqualify you from taking part in this study.

Before the start of treatment, you will participate in a “screening period”, when the study doctor will determine if you are able to enter the study.

You will receive one dose of study drug through an intravenous administration in a vein. You will receive the study drug within 24 hours of your hospital admission. Neither you nor the study doctor will choose what treatment you get.

You will be randomly put into a treatment group by chance to receive either: ● Magnesium Sulfate; or ● Normal Saline You will have a 50% (1 in 2) chance of receiving magnesium sulfate (study drug) and a 50% (1 in 2) chance of receiving normal saline (placebo).

Who can participate

Inclusion criteria:

  • All trauma patients admitted to an adult intensive care unit
  • Signed informed consent
  • Hospital or trauma multimodal pain management order set used for pain management
  • Ages 18-99

Exclusion criteria:

  • Admission to the Pediatric Intensive Care Unit.
  • Head Abbreviated Injury Score (AIS) of greater than 1
  • Known heart failure with reduced ejection fraction (EF < 40%)
  • Renal failure (GFR < 60)
  • Cardiac arrhythmia (except for sinus tachycardia)
  • Greater than 5% TBSA burn injuries
  • Moderate to severe alcohol withdrawal protocol ordered for patient
  • Regular use of opioids in the week prior to injury
  • Receiving continuous infusion of opioids
  • Patients expected to require general anesthesia between 24 and 48 hours after admission (during study drug administration)
  • Patients unable to provide consent is unavailable
  • Patients unable to provide a pain score
  • Pregnancy
  • Prisoners
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 3-4 days.
Recruitment period
From Oct. 14, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Coleman, Lauren
Research Topic
Conditions:
  • Trauma
  • Acute Pain

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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